PMID- 30707761
OWN - NLM
STAT- MEDLINE
DCOM- 20200114
LR  - 20231014
IS  - 1097-0142 (Electronic)
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 125
IP  - 8
DP  - 2019 Apr 15
TI  - Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in 
      patients with solid tumors, vaccinated before or during chemotherapy: A 
      randomized trial.
PG  - 1301-1312
LID - 10.1002/cncr.31909 [doi]
AB  - BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% 
      efficacy against herpes zoster in adults >/=50 years of age and 68% efficacy in 
      autologous hematopoietic stem cell transplant recipients >/=18 years of age. We 
      report the immunogenicity and safety of RZV administered to patients with solid 
      tumors (STs) before or at the start of a chemotherapy cycle. METHOD: In this 
      phase 2/3 observer-blind, multicenter study (NCT01798056), patients with STs who 
      were >/=18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 
      1-2 months apart and stratified (4:1) according to the timing of the first dose 
      with respect to the start of a chemotherapy cycle (first vaccination 8-30 days 
      before the start or at the start [+/-1 day] of a chemotherapy cycle). 
      Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4(+) T cell 
      frequencies, and vaccine response rates (VRRs) were assessed 1 month after dose 1 
      and 1 and 12 months after dose 2. Reactogenicity and safety were assessed in the 
      total vaccinated cohort through 12 months after dose 2. RESULTS: There were 232 
      participants in the total vaccinated cohort, 185 participants in the 
      according-to-protocol cohort for humoral immunogenicity, and 58 participants in 
      the according-to-protocol cohort for cell-mediated immunogenicity. 
      Postvaccination anti-gE antibody concentrations, gE-specific CD4(+) T cell 
      frequencies and VRRs were higher in RZV recipients than in placebo recipients. 
      Solicited adverse events (AEs) were more frequent among RZV recipients than 
      placebo recipients. Incidence of unsolicited AEs, serious AEs, fatalities, and 
      potential immune-mediated diseases were similar between RZV and placebo 
      recipients. CONCLUSION: RZV was immunogenic in patients with STs receiving 
      immunosuppressive chemotherapies. Humoral and cell-mediated immune responses 
      persisted 1 year after vaccination. No safety concerns were identified.
CI  - (c) 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of 
      American Cancer Society.
FAU - Vink, Peter
AU  - Vink P
AD  - GSK, Rockville, Maryland.
FAU - Delgado Mingorance, Ignacio
AU  - Delgado Mingorance I
AD  - Hospital Infanta Cristina, Badajoz, Spain.
FAU - Maximiano Alonso, Constanza
AU  - Maximiano Alonso C
AD  - Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
FAU - Rubio-Viqueira, Belen
AU  - Rubio-Viqueira B
AD  - Hospital Universitario Quiron Madrid, Pozuelo de Alarcon, Spain.
FAU - Jung, Kyung Hae
AU  - Jung KH
AD  - Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
FAU - Rodriguez Moreno, Juan Francisco
AU  - Rodriguez Moreno JF
AD  - Centro Integral Oncologico Clara Campal, Madrid, Spain.
FAU - Grande, Enrique
AU  - Grande E
AD  - Ramon y Cajal University Hospital, Madrid, Spain.
FAU - Marrupe Gonzalez, David
AU  - Marrupe Gonzalez D
AD  - Hospital Universitario de Mostoles, Madrid, Spain.
FAU - Lowndes, Sarah
AU  - Lowndes S
AD  - Great Western Hospital, Swindon, United Kingdom.
FAU - Puente, Javier
AU  - Puente J
AD  - Medical Oncology Department, Hospital Clinico San Carlos, Madrid, Spain.
FAU - Kristeleit, Hartmut
AU  - Kristeleit H
AD  - Queen Elizabeth Hospital, Woolwich, United Kingdom.
FAU - Farrugia, David
AU  - Farrugia D
AD  - Cheltenham General Hospital, Gloucestershire, United Kingdom.
FAU - McNeil, Shelly A
AU  - McNeil SA
AD  - Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health 
      Authority, Dalhousie University, Halifax, Canada.
FAU - Campora, Laura
AU  - Campora L
AD  - GSK, Wavre, Belgium.
FAU - Di Paolo, Emmanuel
AU  - Di Paolo E
AD  - GSK, Rixensart, Belgium.
FAU - El Idrissi, Mohamed
AU  - El Idrissi M
AD  - GSK, Rixensart, Belgium.
FAU - Godeaux, Olivier
AU  - Godeaux O
AD  - Novadip Biosciences s.a., Mont-Saint-Guibert, Belgium.
FAU - Lopez-Fauqued, Marta
AU  - Lopez-Fauqued M
AD  - GSK, Wavre, Belgium.
FAU - Salaun, Bruno
AU  - Salaun B
AD  - GSK, Rixensart, Belgium.
FAU - Heineman, Thomas C
AU  - Heineman TC
AD  - GSK, King of Prussia, Pennsylvania.
FAU - Oostvogels, Lidia
AU  - Oostvogels L
AD  - GSK, Wavre, Belgium.
CN  - Zoster-028 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01798056
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190201
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Antigens, Viral)
RN  - 0 (Herpes Zoster Vaccine)
RN  - 0 (Vaccines, Synthetic)
SB  - IM
EIN - Cancer. 2020 Jun 15;126(12):2941. PMID: 32441797
MH  - Adjuvants, Immunologic/*administration & dosage
MH  - Adult
MH  - Aged
MH  - Antibodies, Viral/*metabolism
MH  - Antigens, Viral/immunology
MH  - Combined Modality Therapy
MH  - Drug Therapy/*methods
MH  - Female
MH  - Herpes Zoster Vaccine/*administration & dosage/immunology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*drug therapy/immunology
MH  - Treatment Outcome
MH  - Vaccines, Synthetic
MH  - Young Adult
PMC - PMC6766894
OTO - NOTNLM
OT  - herpes zoster vaccine
OT  - immunogenicity
OT  - immunosuppressive chemotherapy
OT  - patients with solid tumors
OT  - safety
COIS- Peter Vink, Laura Campora, Emmanuel Di Paolo, Mohamed El Idrissi, Olivier 
      Godeaux, Marta Lopez-Fauqued, Bruno Salaun, Thomas C. Heineman, and Lidia 
      Oostvogels were employees of the GSK group of companies (GSK) at the time this 
      study was designed, initiated, and/or conducted. Lidia Oostvogels was an employee 
      of CureVacAG as of March 1, 2018, and is an inventor on a patent application 
      related to the vaccine used in this study. Thomas C. Heineman was a paid GSK 
      consultant during manuscript development and is an inventor on a patent 
      application related to the study vaccine. Peter Vink, Laura Campora, Emmanuel Di 
      Paolo, Mohamed El Idrissi, Olivier Godeaux, Bruno Salaun, Thomas C. Heineman, and 
      Lidia Oostvogels hold shares/ stock options in GSK. Hartmut Kristeleit reports 
      fees for consultancy and/or speaker bureau activities from Amgen, Roche, and 
      Eisai. Shelly A. McNeil's institution has a clinical trial contract with Novartis 
      and has received research grants for conduct of clinical trials by GSK, Merck, 
      Pfizer, and Sanofi Pasteur. Shelly A. McNeil has received honoraria for 
      participation in scientific advisory boards from GSK, Pfizer, Sanofi Pasteur, and 
      Merck and for provision of accredited CME to HCPs on adult immunization and 
      zoster vaccines. Belen Rubio-Viqueira has received honoraria for scientific 
      advisory board participation from MSD and Lilly and reports personal fees and 
      support from Roche for provision of training and conference attendance. Constanza 
      Maximiano Alonso has received nonfinancial support from Mundipharma, BMS, 
      Pharmamar, Novartis, Janssen-cilag, MSD, and TEVA and reports personal fees from 
      Sanofi, Pharmamar, Roche, Novartis, Janssen-cilag, and Bayer. Enrique Grande has 
      received honoraria for ad boards, meetings, and/or lectures from Pfizer, BMS, 
      IPSEN, Roche, Eisai, Eusa Pharma, MSD, Sanofi-Genzyme, Adacap, Novartis, Pierre 
      Fabre, Lexicon, and Celgene and has received unrestricted research grants from 
      Pfizer, Astra Zeneca, MTEM/Threshold, Roche, IPSEN and Lexicon. Zostavax is a 
      trademark of Merck Sharpe & Dohme corp. Shingrix is a trademark of the GSK group 
      of companies.
EDAT- 2019/02/02 06:00
MHDA- 2020/01/15 06:00
PMCR- 2019/09/30
CRDT- 2019/02/02 06:00
PHST- 2018/07/30 00:00 [received]
PHST- 2018/10/02 00:00 [revised]
PHST- 2018/10/18 00:00 [accepted]
PHST- 2019/02/02 06:00 [pubmed]
PHST- 2020/01/15 06:00 [medline]
PHST- 2019/02/02 06:00 [entrez]
PHST- 2019/09/30 00:00 [pmc-release]
AID - CNCR31909 [pii]
AID - 10.1002/cncr.31909 [doi]
PST - ppublish
SO  - Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1.